EP3155984B1 - Surgical staple actuating sled with actuation stroke having minimized distance relative to distal staple - Google Patents

Surgical staple actuating sled with actuation stroke having minimized distance relative to distal staple Download PDF

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Publication number
EP3155984B1
EP3155984B1 EP16193965.7A EP16193965A EP3155984B1 EP 3155984 B1 EP3155984 B1 EP 3155984B1 EP 16193965 A EP16193965 A EP 16193965A EP 3155984 B1 EP3155984 B1 EP 3155984B1
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EP
European Patent Office
Prior art keywords
terminal
driver
distal
jaw
staple
Prior art date
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Active
Application number
EP16193965.7A
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German (de)
English (en)
French (fr)
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EP3155984A1 (en
Inventor
Charles J. Scheib
Iv Frederick E. Shelton
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Ethicon LLC
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Ethicon LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • A61B17/105—Wound clamp magazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07257—Stapler heads characterised by its anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07271—Stapler heads characterised by its cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07278—Stapler heads characterised by its sled or its staple holder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07285—Stapler heads characterised by its cutter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0804—Counting number of instruments used; Instrument detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Definitions

  • endoscopic surgical instruments may be preferred over traditional open surgical devices since a smaller incision may reduce the post-operative recovery time and complications. Consequently, some endoscopic surgical instruments may be suitable for placement of a distal end effector at a desired surgical site through the cannula of a trocar. These distal end effectors may engage tissue in a number of ways to achieve a diagnostic or therapeutic effect (e.g., endocutter, grasper, cutter, stapler, clip applier, access device, drug/gene therapy delivery device, and energy delivery device using ultrasonic vibration, RF, laser, etc.). Endoscopic surgical instruments may include a shaft between the end effector and a handle portion, which is manipulated by the clinician.
  • Such a shaft may enable insertion to a desired depth and rotation about the longitudinal axis of the shaft, thereby facilitating positioning of the end effector within the patient. Positioning of an end effector may be further facilitated through inclusion of one or more articulation joints or features, enabling the end effector to be selectively articulated or otherwise deflected relative to the longitudinal axis of the shaft.
  • endoscopic surgical instruments include surgical staplers. Some such staplers are operable to clamp down on layers of tissue, cut through the clamped layers of tissue, and drive staples through the layers of tissue to substantially seal the severed layers of tissue together near the severed ends of the tissue layers.
  • surgical staplers are disclosed in U.S. Pat. No. 4,805,823 , entitled “Pocket Configuration for Internal Organ Staplers,” issued February 21, 1989; U.S. Pat. No. 5,415,334 , entitled “Surgical Stapler and Staple Cartridge,” issued May 16, 1995; U.S. Pat. No. 5,465,895 , entitled “Surgical Stapler Instrument,” issued November 14, 1995; U.S. Pat. No.
  • surgical staplers referred to above are described as being used in endoscopic procedures, it should be understood that such surgical staplers may also be used in open procedures and/or other non-endoscopic procedures.
  • a surgical stapler may be inserted through a thoracotomy, and thereby between a patient's ribs, to reach one or more organs in a thoracic surgical procedure that does not use a trocar as a conduit for the stapler.
  • Such procedures may include the use of the stapler to sever and close a vessel leading to a lung. For instance, the vessels leading to an organ may be severed and closed by a stapler before removal of the organ from the thoracic cavity.
  • surgical staplers may be used in various other settings and procedures.
  • 2014/0239042 entitled “Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler,” published August 28, 2014; U.S. Patent Pub. No. 2014/0239036 , entitled “Jaw Closure Feature for End Effector of Surgical Instrument,” published August 28, 2014; U.S. Patent Pub. No. 2014/0239040 , entitled “Surgical Instrument with Articulation Lock having a Detenting Binary Spring,” published August 28, 2014; U.S. Patent Pub. No. 2014/0239043 , entitled “Distal Tip Features for End Effector of Surgical Instrument,” published August 28, 2014; U.S. Patent Pub. No.
  • EP 2583630 relates to a surgical stapler that includes an anvil assembly and a cartridge assembly.
  • the anvil assembly defines staple forming depressions.
  • One or both of the anvil assembly and the cartridge assembly are pivotable relative to the other between an open position and a clamped position.
  • the cartridge assembly includes a first plurality of staples and a second plurality of staples.
  • the first plurality of staples is initially positioned in alignment with the staple forming depressions of the anvil assembly for ejection from the cartridge assembly.
  • the second plurality of staples is movably supported in the cartridge assembly from a first position misaligned with the staple forming depressions of the anvil assembly to a second position aligned with the staple forming depressions for subsequent ejection from the cartridge assembly.
  • EP 2586379 relates to a surgical stapling apparatus and method of use that includes a cartridge assembly which is capable of being reloaded during a surgical procedure without being removed from the surgical site. This allows a surgeon to continue a surgical operation without withdrawing or removing the surgical stapler for reloading and thus reduces the length of the surgery while allowing the physician to concentrate solely on the surgical procedure rather than dividing attention between the surgical procedure and reloading of the surgical stapler.
  • the surgical stapling apparatus includes an elongate member having a plurality of fasteners arranged in a plurality of longitudinally extending rows which is longitudinally translatable through the cartridge to position the plurality of fasteners relative to a plurality of retention slots extending through an upper surface of the cartridge.
  • FIG. 1 depicts an exemplary surgical stapling and severing instrument (10) that includes a handle assembly (20), a shaft assembly (30), and an end effector (40).
  • End effector (40) and the distal portion of shaft assembly (30) are sized for insertion, in a nonarticulated state as depicted in FIG. 1 , through a trocar cannula to a surgical site in a patient for performing a surgical procedure.
  • a trocar may be inserted in a patient's abdomen, between two of the patient's ribs, or elsewhere.
  • instrument (10) is used without a trocar.
  • end effector (40) and the distal portion of shaft assembly (30) may be inserted directly through a thoracotomy or other type of incision.
  • terms such as “proximal” and “distal” are used herein with reference to a clinician gripping handle assembly (20) of instrument (10).
  • end effector (40) is distal with respect to the more proximal handle assembly (20).
  • spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings.
  • surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
  • handle assembly (20) of the present example comprises pistol grip (22), a closure trigger (24), and a firing trigger (26). Each trigger (24, 26) is selectively pivotable toward and away from pistol grip (22) as will be described in greater detail below.
  • Handle assembly (20) further includes an anvil release button (25), a firing beam reverse switch (27), and a removable battery pack (28). These components will also be described in greater detail below.
  • handle assembly (20) may have a variety of other components, features, and operabilities, in addition to or in lieu of any of those noted above.
  • Other suitable configurations for handle assembly (20) will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • shaft assembly (30) of the present example comprises an outer closure tube (32), an articulation section (34), and a closure ring (36), which is further coupled with end effector (40).
  • Closure tube (32) extends along the length of shaft assembly (30).
  • Closure ring (36) is positioned distal to articulation section (34).
  • Closure tube (32) and closure ring (36) are configured to translate longitudinally relative to handle assembly (20). Longitudinal translation of closure tube (32) is communicated to closure ring (36) via articulation section (34). Exemplary features that may be used to provide longitudinal translation of closure tube (32) and closure ring (36) will be described in greater detail below.
  • Articulation section (34) is operable to laterally deflect closure ring (36) and end effector (40) laterally away from the longitudinal axis (LA) of shaft assembly (30) at a desired angle ( ⁇ ). End effector (40) may thereby reach behind an organ or approach tissue from a desired angle or for other reasons.
  • articulation section (34) enables deflection of end effector (40) along a single plane.
  • articulation section (34) enables deflection of end effector along more than one plane.
  • articulation is controlled through an articulation control knob (35) which is located at the proximal end of shaft assembly (30).
  • Knob (35) is rotatable about an axis that is perpendicular to the longitudinal axis (LA) of shaft assembly (30).
  • Closure ring (36) and end effector (40) pivot about an axis that is perpendicular to the longitudinal axis (LA) of shaft assembly (30) in response to rotation of knob (35).
  • rotation of knob (35) clockwise may cause corresponding clockwise pivoting of closure ring (36) and end effector (40) at articulation section (34).
  • Articulation section (34) is configured to communicate longitudinal translation of closure tube (32) to closure ring (36), regardless of whether articulation section (34) is in a straight configuration or an articulated configuration.
  • articulation section (34) and/or articulation control knob (35) are/is constructed and operable in accordance with at least some of the teachings of U.S. Pub. No. 2014/0243801 , entitled “Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks,” published August 28, 2014. Articulation section (34) may also be constructed and operable in accordance with at least some of the teachings of U.S. Pat. App. No. 14/314,125 , entitled “Articulation Drive Features for Surgical Stapler,” filed June 25, 2014; and/or in accordance with the various teachings below. Other suitable forms that articulation section (34) and articulation knob (35) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • shaft assembly (30) of the present example further includes a rotation knob (31).
  • Rotation knob (31) is operable to rotate the entire shaft assembly (30) and end effector (40) relative to handle assembly (20) about the longitudinal axis (LA) of shaft assembly (30).
  • rotation knob (31) is operable to selectively lock the angular position of shaft assembly (30) and end effector (40) relative to handle assembly (20) about the longitudinal axis (LA) of shaft assembly (30).
  • rotation knob (31) may be translatable between a first longitudinal position, in which shaft assembly (30) and end effector (40) are rotatable relative to handle assembly (20) about the longitudinal axis (LA) of shaft assembly (30); and a second longitudinal position, in which shaft assembly (30) and end effector (40) are not rotatable relative to handle assembly (20) about the longitudinal axis (LA) of shaft assembly (30).
  • shaft assembly (30) may have a variety of other components, features, and operabilities, in addition to or in lieu of any of those noted above.
  • at least part of shaft assembly (30) is constructed in accordance with at least some of the teachings of U.S. Pub. No. 2014/0239038 , entitled "Surgical Instrument with Multi-Diameter Shaft,” published August 28, 2014.
  • Other suitable configurations for shaft assembly (30) will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • end effector (40) of the present example includes a lower jaw (50) and a pivotable anvil (60).
  • Anvil (60) includes a pair of integral, outwardly extending pins (66) that are disposed in corresponding curved slots (54) of lower jaw (50).
  • Anvil (60) is pivotable toward and away from lower jaw (50) between an open position (shown in FIGS. 2 and 4 ) and a closed position (shown in FIGS. 1 , 3 , and 7A-7B ).
  • Use of the term "pivotable” (and similar terms with "pivot" as a base) should not be read as necessarily requiring pivotal movement about a fixed axis.
  • anvil (60) pivots about an axis that is defined by pins (66), which slide along curved slots (54) of lower jaw (50) as anvil (60) moves toward lower jaw (50).
  • the pivot axis translates along the path defined by slots (54) while anvil (60) simultaneously pivots about that axis.
  • the pivot axis may slide along slots (54) first, with anvil (60) then pivoting about the pivot axis after the pivot axis has slid a certain distance along the slots (54).
  • pivotal movement is encompassed within terms such as “pivot,” “pivots,” “pivotal,” “pivotable,” “pivoting,” and the like.
  • some versions may provide pivotal movement of anvil (60) about an axis that remains fixed and does not translate within a slot or channel, etc.
  • lower jaw (50) of the present example defines a channel (52) that is configured to receive a staple cartridge (70).
  • Staple cartridge (70) may be inserted into channel (52), end effector (40) may be actuated, and then staple cartridge (70) may be removed and replaced with another staple cartridge (70).
  • Lower jaw (50) thus releasably retains staple cartridge (70) in alignment with anvil (60) for actuation of end effector (40).
  • lower jaw (50) is constructed in accordance with at least some of the teachings of U.S. Pub. No. 2014/0239044 , entitled "Installation Features for Surgical Instrument End Effector Cartridge," published August 28, 2014. Other suitable forms that lower jaw (50) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • staple cartridge (70) of the present example comprises a cartridge body (71) and a tray (76) secured to the underside of cartridge body (71).
  • the upper side of cartridge body (71) presents a deck (73), against which tissue may be compressed when anvil (60) is in a closed position.
  • Cartridge body (71) further defines a longitudinally extending channel (72) and a plurality of staple pockets (74).
  • a staple (77) is positioned in each staple pocket (74).
  • a staple driver (75) is also positioned in each staple pocket (74), underneath a corresponding staple (77), and above tray (76).
  • staple drivers (75) are operable to translate upwardly in staple pockets (74) to thereby drive staples (77) upwardly through staple pockets (74) and into engagement with anvil (60).
  • Staple drivers (75) are driven upwardly by a wedge sled (78), which is captured between cartridge body (71) and tray (76), and which translates longitudinally through cartridge body (71).
  • Wedge sled (78) includes a pair of obliquely angled cam surfaces (79), which are configured to engage staple drivers (75) and thereby drive staple drivers (75) upwardly as wedge sled (78) translates longitudinally through cartridge (70). For instance, when wedge sled (78) is in a proximal position as shown in FIG.
  • staple drivers (75) are in downward positions and staples (77) are located in staple pockets (74).
  • wedge sled (78) As wedge sled (78) is driven to the distal position shown in FIG. 7B by a translating knife member (80), wedge sled (78) drives staple drivers (75) upwardly, thereby driving staples (77) out of staple pockets (74) and into staple forming pockets (64).
  • staple drivers (75) translate along a vertical dimension as wedge sled (78) translates along a horizontal dimension.
  • staple cartridge (70) may be varied in numerous ways.
  • staple cartridge (70) of the present example includes two longitudinally extending rows of staple pockets (74) on one side of channel (72); and another set of two longitudinally extending rows of staple pockets (74) on the other side of channel (72).
  • staple cartridge (70) includes three, one, or some other number of staple pockets (74) on each side of channel (72).
  • staple cartridge (70) is constructed and operable in accordance with at least some of the teachings of U.S. Pub. No. 2014/0239042 , entitled "Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler," published August 28, 2014.
  • staple cartridge (70) may be constructed and operable in accordance with at least some of the teachings of U.S. Pub. No. 2014/0239044 , entitled “Installation Features for Surgical Instrument End Effector Cartridge,” published August 28, 2014.
  • Other suitable forms that staple cartridge (70) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • anvil (60) of the present example comprises a longitudinally extending channel (62) and a plurality of staple forming pockets (64).
  • Channel (62) is configured to align with channel (72) of staple cartridge (70) when anvil (60) is in a closed position.
  • Each staple forming pocket (64) is positioned to lie over a corresponding staple pocket (74) of staple cartridge (70) when anvil (60) is in a closed position.
  • Staple forming pockets (64) are configured to deform the legs of staples (77) when staples (77) are driven through tissue and into anvil (60).
  • staple forming pockets (64) are configured to bend the legs of staples (77) to secure the formed staples (77) in the tissue.
  • Anvil (60) may be constructed in accordance with at least some of the teachings of U.S. Pub. No. 2014/0239042 , entitled “Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler,” published August 28, 2014; at least some of the teachings of U.S. Pub. No. 2014/0239036 , entitled “Jaw Closure Feature for End Effector of Surgical Instrument,” published August 28, 2014; and/or at least some of the teachings of U.S. Pub. No. 2014/0239037 , entitled “Staple Forming Features for Surgical Stapling Instrument,” published August 28, 2014.
  • Other suitable forms that anvil (60) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • knife member (80) is configured to translate through end effector (40). As best seen in FIGS. 5 and 7A-7B , knife member (80) is secured to the distal end of a firing beam (82), which extends through a portion of shaft assembly (30). As best seen in FIGS. 4 and 6 , knife member (80) is positioned in channels (62, 72) of anvil (60) and staple cartridge (70). Knife member (80) includes a distally presented cutting edge (84) that is configured to sever tissue that is compressed between anvil (60) and deck (73) of staple cartridge (70) as knife member (80) translates distally through end effector (40). As noted above and as shown in FIGS.
  • knife member (80) also drives wedge sled (78) distally as knife member (80) translates distally through end effector (40), thereby driving staples (77) through tissue and against anvil (60) into formation.
  • wedge sled (78) distally as knife member (80) translates distally through end effector (40), thereby driving staples (77) through tissue and against anvil (60) into formation.
  • end effector (40) includes lockout features that are configured to prevent knife member (80) from advancing distally through end effector (40) when a staple cartridge (70) is not inserted in lower jaw (50).
  • end effector (40) may include lockout features that are configured to prevent knife member (80) from advancing distally through end effector (40) when a staple cartridge (70) that has already been actuated once (e.g., with all staples (77) deployed therefrom) is inserted in lower jaw (50).
  • lockout features may be configured in accordance with at least some of the teachings of U.S. Pub. No.
  • anvil (60) is driven toward lower jaw (50) by advancing closure ring (36) distally relative to end effector (40).
  • Closure ring (36) cooperates with anvil (60) through a camming action to drive anvil (60) toward lower jaw (50) in response to distal translation of closure ring (36) relative to end effector (40).
  • closure ring (36) may cooperate with anvil (60) to open anvil (60) away from lower jaw (50) in response to proximal translation of closure ring (36) relative to end effector (40).
  • closure ring (36) and anvil (60) may interact in accordance with at least some of the teachings of U.S. Pub. No.
  • handle assembly (20) includes pistol grip (22) and closure trigger (24).
  • anvil (60) is closed toward lower jaw (50) in response to distal advancement of closure ring (36).
  • closure trigger (24) is pivotable toward pistol grip (22) to drive closure tube (32) and closure ring (36) distally.
  • suitable components that may be used to convert pivotal movement of closure trigger (24) toward pistol grip (22) into distal translation of closure tube (32) and closure ring (36) relative to handle assembly (20) will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • closure trigger (24) When closure trigger (24) reaches a fully pivoted state, such that anvil (60) is in a fully closed position relative to lower jaw (50), locking features in handle assembly (20) lock the position of closure trigger (24) and closure tube (32), thereby locking anvil (60) in a fully closed position relative to lower jaw (50). These locking features are released by actuation of anvil release button (25).
  • Anvil release button (25) is configured and positioned to be actuated by the thumb of the operator hand that grasps pistol grip (22).
  • the operator may grasp pistol grip (22) with one hand, actuate closure trigger (24) with one or more fingers of the same hand, and then actuate anvil release button (25) with the thumb of the same hand, without ever needing to release the grasp of pistol grip (22) with the same hand.
  • closure trigger (24) with one or more fingers of the same hand
  • anvil release button (25) with the thumb of the same hand
  • Other suitable features that may be used to actuate anvil (60) will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • instrument (10) provides motorized control of firing beam (82).
  • instrument (10) includes motorized components that are configured to drive firing beam (82) distally in response to pivoting of firing trigger (26) toward pistol grip (22).
  • a motor (not shown) is contained in pistol grip (22) and receives power from battery pack (28). This motor is coupled with a transmission assembly (not shown) that converts rotary motion of a drive shaft of the motor into linear translation of firing beam (82).
  • firing beam (82) may only be advanced distally when anvil (60) is in a fully closed position relative to lower jaw (50). After firing beam (82) is advanced distally to sever tissue and drive staples (77) as described above with reference to FIGS.
  • the drive assembly for firing beam (82) may be automatically reversed to drive firing beam (82) proximally back to the retracted position (e.g., back from the position shown in FIG. 7B to the position shown in FIG. 7A ).
  • the operator may actuate firing beam reverse switch (27), which may reverse the drive assembly for firing beam (82) in order to retract firing beam (82) to a proximal position.
  • Handle assembly (20) of the present example further includes a bailout feature (21), which is operable to provide a mechanical bailout allowing the operator to manually retract firing beam (82) proximally (e.g., in the event of power loss while firing beam (82) is in a distal position, etc.).
  • the features that are operable to provide motorized actuation of firing beam (82) may be configured and operable in accordance with at least some of the teachings of U.S. Pat. No. 8,210,411 , entitled “Motor-Driven Surgical Instrument,” issued July 3, 2012.
  • the features that are operable to provide motorized actuation of firing beam (82) may be configured and operable in accordance with at least some of the teachings of U.S. Pat. No. 8,453,914 , entitled “Motor-Driven Surgical Cutting Instrument with Electric Actuator Directional Control Assembly,” issued June 4, 2013.
  • the features that are operable to provide motorized actuation of firing beam (82) may be configured and operable in accordance with at least some of the teachings of U.S. Patent App. No. 14/226,142 , entitled “Surgical Instrument Comprising a Sensor System,” filed March 26, 2014.
  • firing beam (82) may be manually actuated in accordance with at least some of the teachings of any other reference cited herein.
  • FIG. 8 shows end effector (40) having been actuated through a single stroke through tissue (90).
  • cutting edge (84) obscured in FIG. 8
  • staple drivers (75) have driven two alternating rows of staples (77) through the tissue (90) on each side of the cut line produced by cutting edge (84).
  • Staples (77) are all oriented substantially parallel to the cut line in this example, though it should be understood that staples (77) may be positioned at any suitable orientations.
  • end effector (40) is withdrawn from the trocar after the first stroke is complete, the spent staple cartridge (70) is replaced with a new staple cartridge (70), and end effector (40) is then again inserted through the trocar to reach the stapling site for further cutting and stapling. This process may be repeated until the desired amount of cuts and staples (77) have been provided.
  • Anvil (60) may need to be closed to facilitate insertion and withdrawal through the trocar; and anvil (60) may need to be opened to facilitate replacement of staple cartridge (70).
  • cutting edge (84) may cut tissue substantially contemporaneously with staples (77) being driven through tissue during each actuation stroke.
  • cutting edge (84) just slightly lags behind driving of staples (77), such that staple (77) is driven through the tissue just before cutting edge (84) passes through the same region of tissue, though it should be understood that this order may be reversed or that cutting edge (84) may be directly synchronized with adjacent staples.
  • FIG. 8 shows end effector (40) being actuated in two layers (92, 94) of tissue (90), it should be understood that end effector (40) may be actuated through a single layer of tissue (90) or more than two layers (92, 94) of tissue.
  • FIG. 8 shows end effector (40) being actuated in two substantially flat, apposed planar layers (92, 94) of tissue, it should be understood that end effector (40) may also be actuated across a tubular structure such as a blood vessel, a section of the gastrointestinal tract, etc.
  • FIG. 8 should therefore not be viewed as demonstrating any limitation on the contemplated uses for end effector (40).
  • instrument (10) may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • instrument (10) may be configured and operable in accordance with any of the various references cited herein. Additional exemplary modifications that may be provided for instrument (10) will be described in greater detail below. Various suitable ways in which the below teachings may be incorporated into instrument (10) will be apparent to those of ordinary skill in the art. Similarly, various suitable ways in which the below teachings may be combined with various teachings of the references cited herein will be apparent to those of ordinary skill in the art. It should also be understood that the below teachings are not limited to instrument (10) or devices taught in the references cited herein. The below teachings may be readily applied to various other kinds of instruments, including instruments that would not be classified as surgical staplers. Various other suitable devices and settings in which the below teachings may be applied will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • a liver includes tissue including vessels or ducts passing throughout.
  • the resection may be anatomic (e.g., resection of the right or left side of the liver, inclusive of the lobes on that side) or non-anatomic (e.g., resection of just a single lobe or wedge of liver tissue).
  • This resection process may entail at least three kinds of steps - a first step to dissect the tissue (e.g., liver parenchyma) around the vessels or ducts, to thereby isolate or reveal the vessels or ducts; a second step to ligate those vessels or ducts; and a third step to sever the ligated vessels or ducts.
  • tissue e.g., liver parenchyma
  • liver resection includes the well known Kelly clamp method, where a Kelly style clamp is used to compress the liver tissue and thereby dissect the tissue through a crushing action.
  • treatments may require many instruments to accommodate such a wide variety of tissues and vessels or ducts within the human body, thereby adding to the time and complexity associated with assessing the state of the tissue, selecting and/or changing instruments, and performing the resection.
  • It may therefore be desirable to provide a surgical instrument (410) with an end effector (412) having a pair of crush surfaces (414, 416) that are configured to sever tissue by crushing the tissue; while also providing an adjacent staple cartridge (418) to selectively ligate one or more vessels or ducts passing through the tissue.
  • a single surgical instrument (410) will allow the operator to more quickly assess the tissue and proceed with further tissue dissection and/or ligation of vessels and ducts.
  • Surgical instruments (410) are described below in the context of dissecting liver tissue (e.g., liver parenchyma) with crush surfaces (414, 416) and using staples to ligate associated vessels or ducts (e.g., portal vein, hepatic vein branches, hepatic artery branches, extrahepatic vessels, etc.).
  • associated vessels or ducts e.g., portal vein, hepatic vein branches, hepatic artery branches, extrahepatic vessels, etc.
  • the vessel or duct that is sealed by the staples is exposed when the operator crushes the liver tissue with surfaces (414, 416).
  • the vessel or duct that is sealed by the staples is separate from the liver tissue that the operator has crushed with surfaces (414, 416).
  • surgical instruments (410) and method of treatment are provided in the context of liver resection, it will be appreciated that surgical instruments (410) may be alternatively configured to treat any tissue in the human body with similar features. It should also be understood that that the features discussed below may be readily incorporated into surgical instrument (10) discussed above. To this end, like numbers indicate like features described above in greater detail.
  • end effectors (412) apply at least two laterally spaced apart rows of staples where the staples in one row have the same height as the staples in another row. In some variations, end effectors (412) are modified to apply at least two laterally spaced apart rows of staples where the staples in one row have a height that is different from the height of the staples in another row.
  • FIGS. 9-13 show surgical instrument (410) with end effector (412) having upper crush surface (414), lower crush surface (416), staple cartridge (418), and knife member (419).
  • end effector (412) having crush surfaces (414, 416) that are configured to sever tissue by crushing the tissue; while also providing adjacent staple cartridge (418) to selectively ligate one or more vessels passing through the tissue.
  • knife member (419) is configured to cut the one or more vessels for complete removal of the surrounding tissue.
  • Surgical instrument (410) of the present example also includes handle assembly (20) and shaft assembly (30) discussed above in greater detail. Except as otherwise described below, end effector (412), in conjunction with handle assembly (20) and shaft assembly (30), is configured and operable similar to end effector (40) (see FIG. 1 ).
  • end effector (412) may have a length of approximately 40 mm and a width of approximately 7mm. Alternatively, any other suitable dimension may be used.
  • End effector (412) of the present example includes a lower jaw (420) and an upper jaw (422), which forms an anvil (424).
  • Upper jaw (422) is pivotally mounted relative to lower jaw (420) for receiving the tissue therebetween.
  • anvil (424) is pivotable toward and away from lower jaw (420) between an open position and a closed position (e.g., in response to pivotal movement of trigger (24) toward and away from pistol grip (22)).
  • anvil (424) pivots about an axis that is defined by pins (not shown), which slide along curved slots (not shown) of lower jaw (420) as anvil (424) moves toward lower jaw (420).
  • the pivot axis translates along the path defined by slots (not shown) while anvil (424) simultaneously pivots about that axis.
  • the pivot axis may slide along slots (not shown) first, with anvil (424) then pivoting about the pivot axis after the pivot axis slides a certain distance along the slots (not shown).
  • some versions may provide pivotal movement of anvil (424) about an axis that remains fixed and does not translate within a slot or channel, etc.
  • lower jaw (420) of the present example defines a channel (426) that is configured to receive staple cartridge (418).
  • Staple cartridge (418) may be inserted into channel (426), end effector (412) may be actuated, and then staple cartridge (418) may be removed and replaced with another staple cartridge (418).
  • Lower jaw (420) thus releasably retains staple cartridge (418) in alignment with anvil (424) for actuation of end effector (412).
  • the components of staple cartridge (418) are fully integrated into lower jaw (420) such that end effector (412) may only be used once.
  • Other suitable forms that lower jaw (420) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • lower and upper jaws (420, 422) extend to a distal tip (432), which is further defined by staple cartridge (418).
  • Staple cartridge (418) of the present example comprises a cartridge body (434) and a tray (436) (see FIG. 36) secured to an underside of cartridge body (434).
  • An upper side of cartridge body (434) presents a deck (438), against which tissue may be compressed when anvil (424) is in a closed position.
  • lower crush surface (416) is positioned along staple cartridge (418).
  • lower crush surface (416), as well as cooperating upper crush surface (414) may be alternatively positioned along end effector (412) for severing tissue via compression.
  • Cartridge body (434) further defines an elongated channel (439) extending through lower jaw (420) and linearly along a centerline (440) of end effector (412).
  • Another elongated channel (441) defined by anvil (424) extends through upper jaw (422) and linearly along centerline (440), as well, for reasons discussed below in greater detail.
  • a plurality of staple pockets (442) follow a predetermined pattern along deck (438) on opposing sides of centerline (440).
  • staple cartridge (418) includes two longitudinally extending rows of staple pockets (442) on one side of centerline (440); and another set of two longitudinally extending rows of staple pockets (442) on the other side of centerline (440).
  • staple cartridge (418) may include three, one, or some other number of staple pockets (442) on each side of centerline (440).
  • One of a plurality of staples (444) is positioned in respective staple pockets (442).
  • Adjacent rows of staple pockets (442) are configured to overlap in a direction transverse to the centerline (440) in order to install the plurality of staples (444) within the tissue and inhibit openings therebetween for improved ligation.
  • a consistent gap (G1) is maintained between adjacent staple pockets (442) for consistent overlap in the present example.
  • overlap is intended to include one feature overlapping with another in at least one direction.
  • a feature may be offset from another feature and still overlap as described herein in the event that these features overlap in at least one plane, such as a transverse plane including the transverse direction.
  • Other suitable forms that staple cartridge (418) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • anvil (424) of the present example has a plurality of staple forming pockets (446).
  • Each staple forming pocket (446) is positioned to lie over a corresponding staple pocket (442) of staple cartridge (418) when anvil (424) is in a closed position.
  • Staple forming pockets (446) are configured to deform each leg (448) of staples (444) when staples (444) are driven through tissue and into anvil (424).
  • staple forming pockets (446) are configured to bend legs (448) of staples (444) to secure the formed staples (444) in the tissue.
  • Other suitable forms that anvil (424) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • staple cartridge (418) includes staple drivers (452) positioned in staple pockets (442), underneath a corresponding staple (444), and above tray (436) (see FIG. 36).
  • staple drivers (452) are operable to translate upwardly in staple pockets (442) to thereby drive staples (444) upwardly through staple pockets (442) and into engagement with anvil (424).
  • Staple drivers (452) are driven upwardly by a wedge sled (456), which is captured between cartridge body (434) and tray (436) (see FIG. 36), and which translates longitudinally through cartridge body (434) along a pair of cam slots (457).
  • Wedge sled (456) includes a cam ramp (258) having a leading cam surface (460), an intermediate cam surface (462), and a trailing cam surface (464).
  • leading cam surface (460) may be angled at approximately 45° relative to a horizontal plane; and intermediate cam surface (462) may be angled at approximately 22° relative to a horizontal plane.
  • Cam ramps (458) are generally configured to engage staple drivers (452) and thereby drive staple drivers (452) upwardly as wedge sled (456) translates longitudinally through staple cartridge (418) from a proximal sled position to a distal sled position.
  • wedge sled (456) when wedge sled (456) is in the proximal sled position, staple drivers (452) are in downward positions and staples (444) are located in staple pockets (442).
  • wedge sled (456) As wedge sled (456) is driven to the distal sled position by translating knife member (419), wedge sled (456) drives staple drivers (452) upwardly, thereby driving staples (444) out of staple pockets (442) and into staple forming pockets (446).
  • staple drivers (452) translate along respective vertical planes as wedge sled (456) translates along a horizontal plane.
  • knife member (419) is configured to translate through end effector (412). As best seen in FIG. 13 , knife member (419) is secured to a distal end of firing beam (82), which extends through a portion of shaft assembly (30). Knife member (80) is positioned in channels (439, 441) of staple cartridge (418) and anvil (424), respectively. Knife member (419) includes a distally presented cutting edge (468) that is configured to sever tissue that is compressed between anvil (424) and deck (438) of staple cartridge (418) as knife member (419) translates distally through end effector (412). As noted above, knife member (419) also drives wedge sled (456) distally as knife member (419) translates distally through end effector (412), thereby driving staples (444) through tissue and against anvil (424) into formation.
  • wedge sled (456) slides distally until its translational movement along centerline (440) is blocked by distal tip (432) of staple cartridge (418). As such, wedge sled (456) effectively parks underneath terminal staple drivers (452), which in conjunction with tray (436) define a storage space (506) for wedge sled (456) therebetween. In other words, distal tip (432) inhibits distal movement of wedge sled (456) such that a majority of wedge sled (456) cannot slide distally beyond terminal staple drivers (452).
  • cam ramps (458) of wedge sled (456) are received within a pair of lower apertures (508) of distal tip (432) that further defines storage space (506), such that only a minor distal portion of wedge sled (456) slides distally beyond staple drivers (452), as shown in FIG. 14 and FIG. 15 .
  • cam surfaces (460, 462, 464) do not fully traverse the length of the crown of the distal-most staple (444).
  • Triple driver assembly (492), wedge sled (456), and distal tip (432) are thus collectively configured to reduce elongation of distal tip (432) of end effector (412) for improved access to tissue within patients.
  • distal staple driver (452) is cantilevered distally beyond driver cam (494) to increase the distal most position of staple (444), while providing additional storage space (506) defined underneath.
  • wedge sled (456) includes multiple leading and intermediate cam surfaces (460, 462) to result in the shortened length of cam ramp (458).
  • lower apertures (508) within distal tip (432) provide for final translation along centerline (440) without further distal elongation of distal tip (432).
  • triple driver assembly (492), wedge sled (456), and distal tip (432) are each configured in part to reduce travel of wedge sled (456) and reduce elongation of distal tip (432) of end effector (412) for improved access.
  • very close longitudinal positioning of the distal-most staple pockets (446) to distal tip (432) will minimize the occurrence of tissue being severed by crush surfaces (414, 416) at regions that are distal to the distal-most staple (444).
  • FIGS. 16A-16E show one example of using end effector (412) to resect tissue, such as a liver parenchyma tissue (310), and to ligate a vessel or duct (316) therein.
  • vessel or duct (316) may comprise a hepatic vein or a hepatic artery. It should also be understood that the method may further include the use of end effector (412) to ligate other vessels such as the portal vein and extrahepatic vessels, etc.
  • the operator positions end effector (412) such that tissue (310), including vessel or duct (316), is located between lower and upper jaws (420, 422).
  • tissue (310) including vessel or duct (316)
  • the operator then compresses tissue (310) between upper and lower crush surfaces (414, 416) of upper and lower jaws (420, 422), respectively, to deliver the predetermined crush pressure to tissue (310).
  • jaws (420, 422) may be actuated in this manner by pivoting trigger (24) toward pistol grip (22). It should be understood that jaws (420, 422) need not necessarily be actuated to a fully closed configuration.
  • the operator may rely on tactile feedback through trigger (24) and pistol grip (22) to determine whether the operator has achieved a desired gap between jaws (420,422) to suitably crush tissue (310) without undesirably damaging vessel or duct (316).
  • the operator may rely on visual feedback.
  • the crush pressure applied by jaws (420, 422) effectively severs tissue (310), and the operator then removes end effector (412) from tissue (310) to view whether or not any vessels or ducts are present.
  • end effector (412) As shown in FIG. 16C , vessel or duct (316) remains intact and is left exposed, extending between severed portions of tissue (310).
  • the operator may leave vessel or duct (316) intact.
  • the operator ligates vessel or duct (316) to complete the resection of a severed portion of tissue (310), as shown in FIG. 16D .
  • Ligation includes placement of at least some of overlapping staples (444) within vessel or duct (316) as discussed above in greater detail. It should therefore be understood that the same end effector (412) may be used to crush (and thereby sever) tissue (310) of the liver and also ligate a vessel or duct (316) in the tissue (310).
  • the vessel or duct (316) is stapled and severed substantially simultaneously by end effector (412), resulting in the configuration shown in FIG. 16E .
  • the severed end (318) of the vessel or duct (316) is sealed by staples (444). Thereby, the operator completes resection of a right portion of tissue (310) and the corresponding portion of the vessel or duct (316).
  • the operator removes end effector (412) for viewing vessel (316) as shown in FIG. 16C .
  • the operator may apply the predetermined crush pressure (or as determined based on tactile and/or visual feedback as noted above), as shown in FIG. 16B , and immediately thereafter sever and ligate any tissue remaining therein, such as vessel or duct (316).
  • the operator may find such viewing desirable in one or more liver resection procedures.
  • tissue resection with end effector (412) may be performed on other tissues within the patient as desired by the user.
  • 2012/0199630 entitled “Robotically-Controlled Surgical Instrument with Force-Feedback Capabilities,” published August 9, 2012; U.S. Pub. No. 2012/0132450 , entitled “Shiftable Drive Interface for Robotically-Controlled Surgical Tool,” published May 31, 2012; U.S. Pub. No. 2012/0199633 , entitled “Surgical Stapling Instruments with Cam-Driven Staple Deployment Arrangements,” published August 9, 2012; U.S. Pub. No. 2012/0199631 , entitled “Robotically-Controlled Motorized Surgical End Effector System with Rotary Actuated Closure Systems Having Variable Actuation Speeds,” published August 9, 2012; U.S. Pub. No.
  • 2012/0199632 entitled “Robotically-Controlled Surgical Instrument with Selectively Articulatable End Effector,” published August 9, 2012; U.S. Pub. No. 2012/0203247 , entitled “Robotically-Controlled Surgical End Effector System,” published August 9, 2012; U.S. Pub. No. 2012/0211546 , entitled “Drive Interface for Operably Coupling a Manipulatable Surgical Tool to a Robot,” published August 23, 2012; U.S. Pub. No. 2012/0138660 , entitled “Robotically-Controlled Cable-Based Surgical End Effectors,” published June 7, 2012; and/or U.S. Pub. No. 2012/0205421 , entitled “Robotically-Controlled Surgical End Effector System with Rotary Actuated Closure Systems,” published August 16, 2012.
  • Versions of the devices described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a operator immediately prior to a procedure.
  • reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
  • versions described herein may be sterilized before and/or after a procedure.
  • the device is placed in a closed and sealed container, such as a plastic or TYVEK bag.
  • the container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons.
  • the radiation may kill bacteria on the device and in the container.
  • the sterilized device may then be stored in the sterile container for later use.
  • a device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

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RU2018117702A (ru) 2019-11-15
JP6862436B2 (ja) 2021-04-21
EP3155984A1 (en) 2017-04-19
WO2017066082A1 (en) 2017-04-20
US10226251B2 (en) 2019-03-12
BR112018007456B1 (pt) 2022-11-16
RU2018117702A3 (ja) 2020-02-26
CN108135608B (zh) 2021-07-02
RU2728723C2 (ru) 2020-07-30
BR112018007456A2 (pt) 2018-10-23
JP2018532491A (ja) 2018-11-08
CN108135608A (zh) 2018-06-08
US20170105729A1 (en) 2017-04-20

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